DSBS kursus i Clinical Trial Simulation

Clinical Trial Simulation

27 – 28 Marts 2006

Presenters: Ulrika Simonsson and Judith L. Jacobsen

Ulrika Simonsson, PhD. is Associate Professor at Div of Pharmacokinetics and Drug Therapy, Dept of Pharmaceutical Sciences, Uppsala University, Sweden. Judith L. Jacobsen, PhD. is a senior statistical consultant at Statcon ApS.

In the whitepaper “Innovation or Stagnation: Crisis on the Critical Path to New Medical Products” FDA have presented their concern, that “Despite broad progress in the scientific and technical areas of the drug development process, the development of novel candidate molecular entities into safe and effective new drugs remains a laborious, inefficient, time-consuming and expensive process that has not changed appreciably in decades. To the extent that systemic inadequacies in the drug development process result in excessive risks, costs, and prolongation of safety and efficacy evaluation, society as a whole is adversely affected.” To improve that situation, “Model-based Drug Development” is suggested.

Model-based drug development uses drug and disease models to aggregate and integrate knowledge, over time, for the drug effect(s), disease progression, dose response, relevant covariates and efficacy/safety/toxicity. This model-based approach becomes the basis of clinical trial simulation and leads to improved decision-making in clinical drug development. Clinical trial simulation (CTS), utilizes the computer to simulate virtual patients in the clinical research context, has been applied to better understand possible trial outcomes to optimize clinical study design and clinical planning. This course presents a general framework for Clinical trial Simulation, concerning the planning, conduct and reporting of simulated trials. The course will cover topics like how modeling and simulation can contribute to drug development, simulation in Drug development, good practice and regulatory viewpoints, simulation strategies, planning a CTS project, interpretation of simulation results, different software used in CTS and practical hands-on exercises.

In addition to lectures, there will be discussions based on examples of simulated trials.

During the last session of the course, there will be an opportunity for participants to share their experiences of planning and conducting Clinical trial Simulation and discuss issues that have arisen. Also the issue of the interdisciplinary collaborations needed, when conducting a simulated trial will be discussed with the participants.

Program

• The modeling and simulation (M&S) process (Incl. The role of the pharmacometrician)
• PKPD modeling and simulation in the different development Phases
• Planning a Clinical Trial Simulation (CTS) project, Design issues and Analysis Plan
• Model development and discussion of different types of models (Nonlinear mixed effects, standard two stage modeling, empirical and mechanistic models).
• Building and validating a simulation model
• Interpretation of simulation results
• Different software (including Splus scripting)
• Regulatory perspectives of CTS
• Simulation in Drug development – good practice
• Example and exercises